Medical device regulations in Georgia have significantly tightened in recent years, aligning closely with EU standards. The import and sale of medical products (equipment, consumables, diagnostic tools) require strict compliance with regulatory requirements, including state registration, labeling, and quality control. Improperly documented imports often lead to cargo being held at customs, which is critical for perishable or urgently needed medical supplies. Additionally, certain categories of medical goods enjoy tax exemptions (e.g., VAT exemption), the utilization of which requires knowledge of specific codes and documentation. Consequently, this field demands a synthesis of pharmaceutical law and customs/tax regulations.
What Do Medical Device Regulation Services Cover?
Specialists on Legal.ge assist importers and distributors in gaining smooth market access for their products. The services include:
- State Registration: Registering medical devices with the Regulation Agency of the Ministry of Health, preparing dossiers, and submission.
- Customs Classification: Correctly classifying goods (assigning HS codes) to determine if they qualify for VAT exemption or require special permits.
- Labeling and Marking Consultation: Preparing Georgian labels and instructions in compliance with legislation, which is mandatory for sale.
- Permit Acquisition: Obtaining import permits for equipment subject to special control (e.g., containing radioactive sources).
- Compliance Audit: Reviewing existing processes to determine the company's readiness for inspections conducted by the regulator.
Common Situations and Scenarios
In practice, it is common for an importer to bring in expensive equipment (e.g., ultrasound machines), only to find at customs that it has not undergone registration or its CE certificate is not recognized. This leads to cargo detention in warehouses and accumulating daily fines. A second scenario involves VAT payment: a company imports a dental chair and pays 18% VAT, whereas by specifying the correct code and confirming medical purpose, they could have benefited from an exemption. Labeling is also critical—if a product on the market lacks instructions in Georgian, the company is fined, and the product is subject to recall.
Georgian Legal Framework
The field is primarily regulated by the Law of Georgia on Medicine and Pharmaceutical Activities, which also covers medical devices. Registration rules are outlined in Government Resolutions. From a tax perspective, the Tax Code of Georgia is important as it defines the rules for VAT exemption on medical goods. The regulatory body is the Agency for Regulation of Medical and Pharmaceutical Activities, which oversees the market.
Step-by-Step Service Process
Working with an expert on Legal.ge begins with product classification. In the first stage, it is determined whether the item constitutes a "medical device" under the law. In the second stage, registration documentation (manufacturer authorization, quality certificates, clinical trials) is prepared and submitted to the Agency. The third stage involves managing the import process in coordination with a customs broker to utilize tax incentives. In the final stage, the expert checks the visual aspect (label) of the product before it enters the retail network to rule out fines.
Why Choose Legal.ge?
Regulations in the medical field are constantly changing. Legal.ge gives you access to lawyers specializing in Health Law who are well-versed in the requirements of the Regulation Agency. Our specialists will help you not only navigate bureaucratic procedures but also optimize tax costs, making your business more competitive.
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